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ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Secondary Hyperparathyroidism

Intervention: Sensipar® (Drug); Vitamin D (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P) product.

Clinical Details

Official title: ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Sensipar® and Low Dose Vitamin D vs. Escalating Doses of Vitamin D Alone

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Achieving the NKF-K/DOQI targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (less than 55 mg^2/dL^2) during the assessment phase

Secondary outcome:

Absolute Change from Baseline for P During the Assessment Phase

Proportion of Participants with ≥ 30% Reduction from Baseline in Mean iPTH During the Assessment Phase

Percent Change from Baseline for Calcium During the Assessment Phase

Percent Change from Baseline for Phosphorus During the Assessment Phase

Percent Change from Baseline for Ca x P During the Assessment Phase

Percent Change from Baseline for iPTH During the Assessment Phase

Proportion of Participants who Attained the K/DOQI Target Range for Ca x P During the Assessment Phase.

Proportion of Participants who Attained the K/DOQI Target Range for Ca During the Assessment Phase

Proportion of Participants who Attained the K/DOQI Target Range for iPTH During the Assessment Phase

Proportion of Participants who Attained the K/DOQI Target Range for P During the Assessment Phase.

Absolute Change from Baseline for iPTH During the Assessment Phase

Absolute Change from Baseline for Ca During the Assessment Phase

Absolute Change from Baseline for Ca x P During the Assessment Phase

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: - On hemodialysis for at least 3 months and have received intravenous

vitamin D therapy (paricalcitol or doxercalciferol) for at least 3 months prior to

entering screening - Historical iPTH 150-800 pg/ml (or biPTH 80-430 pg/ml) within 6 months

and corrected serum Ca greater than 8. 4 mg/dl within 2 months prior to screening period. For subjects with biPTH 80-160 pg/ml (iPTH 150-300 pg/ml), Ca x P must be greater than 55

mg²/dl² within 2 months prior to the screening period - Screening (pre-washout) biPTH

80-430 pg/ml and a corrected serum Ca level greater than 8. 4 mg/dl. For subjects with

biPTH 80-160 pg/ml Ca x P must be also greater than 55 mg²/dl² - Baseline mean biPTH

(post-washout) greater than 160 pg/ml and mean corrected Ca greater than 8. 4 mg/dl

Exclusion Criteria: - Parathyroidectomy in the 3 month period prior to screening - Current

gastrointestinal disorder that may be associated with impaired absorption of orally

administered medications or an inability to swallow tablets - Use of investigational drug

or device or participation in a trial of investigational drug or device within 30 days of

screening - Females of child bearing potential who are pregnant (e. g., positive pregnancy

test) or are breast feeding or who refuse to use highly effective contraceptive measures

(as determined by the investigator) throughout the study - Previously participated in this

or any other Sensipar® study or has received or is receiving Sensipar® as a commercially available product

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Related publications:

Fishbane S, Shapiro WB, Corry DB, Vicks SL, Roppolo M, Rappaport K, Ling X, Goodman WG, Turner S, Charytan C. Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results. Clin J Am Soc Nephrol. 2008 Nov;3(6):1718-25. doi: 10.2215/CJN.01040308.

Shireman TI, Almehmi A, Wetmore JB, Lu J, Pregenzer M, Quarles LD. Economic analysis of cinacalcet in combination with low-dose vitamin D versus flexible-dose vitamin D in treating secondary hyperparathyroidism in hemodialysis patients. Am J Kidney Dis. 2010 Dec;56(6):1108-16. doi: 10.1053/j.ajkd.2010.07.012. Epub 2010 Oct 15.

TBD.Sensipar plus low dose vitamin D (ACHIEVE).Journal-004521;

TBD.Time in target.Journal-004521;

Starting date: August 2005
Last updated: February 7, 2014

Page last updated: August 23, 2015

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